Key Takeaways:
Moderna's mRNA flu vaccine cleared its biggest regulatory hurdle yet, setting up a potential August approval that would give the company its third marketed product and the first mRNA-based seasonal flu shot in the U.S.
Moderna Inc.'s experimental influenza vaccine mFlusiva received unanimous backing from the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee on Thursday, with both age-group votes landing at 9-0 that the benefits outweigh the risks for adults 50 and older.
The advisory panel considered two separate votes — one for adults ages 50 to 64 and another for those 65 and older — and approved both without dissent. The outcome marks a sharp reversal from February, when Trump appointee Vinay Prasad, then overseeing vaccines at the FDA, refused to accept Moderna's filing for review, arguing the company should have used a high-dose comparator in older adults rather than the standard-dose vaccine it deployed in its Phase 3 trial.
"The studies that were presented today were very well conducted," VRBPAC voting member Flor Munoz-Rivas, a pediatric infectious disease specialist at Baylor College of Medicine, said after the vote. "They have very clear results that are very robust in terms of demonstrating that additional efficacy."
Moderna's Phase 3 efficacy study P304 enrolled more than 40,000 adults 50 and older and showed the mRNA candidate delivered a 26.6% higher relative vaccine efficacy compared with a licensed standard-dose flu shot. A smaller Phase 3 trial involving nearly 3,000 participants 65 and older demonstrated stronger immune responses than a high-dose vaccine currently recommended for that age group. The most common adverse reactions included injection site pain, fatigue, headache and myalgia, with no significant differences in serious adverse events between trial arms.
The FDA has set an Aug. 5 deadline for its final decision. If approved, mFlusiva would become the first mRNA-based seasonal influenza vaccine available in the U.S., expanding Moderna's commercial portfolio beyond its Covid-19 shot Spikevax and its respiratory syncytial virus vaccine mResvia. Moderna shares rose 3.5% on the news.
The company is pursuing a two-track regulatory strategy: traditional approval for adults 50 to 64 and accelerated approval for those 65 and older, with a commitment to run a confirmatory post-market study in the older cohort. Moderna CEO Stéphane Bancel said the company looks forward to working with the FDA as it completes its review.
A further hurdle awaits at the Centers for Disease Control and Prevention, where the Advisory Committee on Immunization Practices — currently hamstrung by a federal injunction blocking Health Secretary Robert F. Kennedy Jr.'s appointees — would need to issue usage recommendations before insurers and federal programs would be required to cover the shot at no cost. The Department of Health and Human Services is appealing the injunction on an expedited schedule extending into July.
For Moderna, the flu vaccine represents a critical piece of its post-pandemic growth strategy. Evercore ISI analysts said in a client note that FDA approval "could aid a return to growth" for the company while its oncology franchise matures, though they cautioned the flu program alone is not a "fundamental thesis changer." Jefferies analyst Andrew Tsai projects $750 million in U.S. flu and Covid-flu combo vaccine sales by 2030. Moderna has also been reshaping its commercial leadership, hiring a new chief this week and elevating its president as it prepares for multiple product launches.
This article is for informational purposes only and does not constitute investment advice.
